Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)
Authors: Ekaterina Khaleva, Anna Rattu, Chris Brightling, Andrew Bush, Apostolos Bossios, Arnaud Bourdin, Kian Fan Chung, Rekha Chaudhuri, Courtney Coleman, Sven-Erik Dahlén, Ratko Djukanovic, Antoine Deschildre, Louise Fleming, Stephen J. Fowler, Atul Gupta, Eckard Hamelmann, Simone Hashimoto, Gunilla Hedlin, Gerard H. Koppelman, Erik Melén, Clare S. Murray, Charles Pilette, Celeste Porsbjerg, Katharine C. Pike, Franca Rusconi, Clare Williams, Birgit Ahrens, Peter Alter, Freja Anckers, Maarten van den Berge, Katharina Blumchen, Guy Brusselle, Graham W. Clarke, Danen Cunoosamy, Barbro Dahlén, Piers Dixey, Andrew Exley, Urs Frey, Erol A. Gaillard, Lisa Giovannini-Chami, Jonathan Grigg, Diana Hartenstein, Liam G. Heaney, Bülent Karadag, Susanne Kaul, Inger Kull, Amelia Licari, Anke H. Maitland-van der Zee, Vera Mahler, Ann-Marie M. Schoos, Prasad Nagakumar, Jenny Negus, Hanna Nielsen, James Paton, Mariëlle Pijnenburg, Valeria Ramiconi, Sofia Romagosa Vilarnau, Stefania Principe, Niels Rutjes, Sejal Saglani, Paul Seddon, Florian Singer, Heribert Staudinger, Steve Turner, Susanne Vijverberg, Tonya Winders, Valentyna Yasinska, Graham Roberts
Journal: European Respiratory Journal (2022)

Background Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) Working Group sought to develop Core Outcome Measures (COM) sets to facilitate better synthesis of data and appraisal of biologics in paediatric and adult asthma clinical studies. Methods COMSA utilised a multi-stakeholder consensus process among patients with severe asthma, adult and paediatric clinicians, pharmaceutical representatives, and health regulators from across Europe. Evidence included a systematic review of development, validity and reliability of selected outcome measures plus a narrative review and a pan-European survey to better understand patients’ and carers’ views about outcome measures. It was discussed using a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria. Results Both adult and paediatric COM sets include forced expiratory volume in 1 s (FEV 1 ) as z-scores, annual frequency of severe exacerbations and maintenance oral corticosteroid use. Additionally, the paediatric COM set includes the Paediatric Asthma Quality of Life Questionnaire and Asthma Control Test or Childhood Asthma Control Test, while the adult COM set includes the Severe Asthma Questionnaire and Asthma Control Questionnaire-6 (symptoms and rescue medication use reported separately). Conclusions This patient-centred collaboration has produced two COM sets for paediatric and adult severe asthma. It is expected that they will inform the methodology of future clinical trials, enhance comparability of efficacy and effectiveness of biological therapies, and help assess their socioeconomic value. COMSA will inform definitions of non-response and response to biological therapy for severe asthma.